Sinoxal 50 mg prašak za otopinu za infuziju; Sinoxal 100 mg prašak za otopinu za infuziju
Name | Sinoxal 50 mg prašak za otopinu za infuziju; Sinoxal 100 mg prašak za otopinu za infuziju |
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Marketing Authorisation Number | HR-H-640588353 |
Active Substance | oksaliplatin |
Composition | 1 ml rekonstituirane otopine za infuziju sadrži 5 mg oksaliplatina |
Pharmaceutical Form | prašak za otopinu za infuziju |
Manufacturer | Actavis Italy S.p.A. - Nerviano Plant, Nerviano (Milan), Italija;
S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska |
Marketing Authorisation Holder | Actavis Group PTC ehf, Reykjavikurvegur 76-78, Hafnarfjordur, Island |
Marketing Authorisation Date | 30.09.2015 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/14-02/401 |
Registration Number | 381-12-01/70-15-11 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01XA03 |
Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
SmPC | download |
PL | download |